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A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn's Disease

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Trial Profile

A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn's Disease

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 Sep 2021

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At a glance

  • Drugs Vedolizumab (Primary)
  • Indications Crohn's disease
  • Focus Registrational; Therapeutic Use
  • Acronyms GEMINI-III
  • Sponsors Millennium

    • Most Recent Events

    • 22 May 2019 According to a Takeda media release, based on the data from GEMINI II, GEMINI III [NCT01224171] and CCT001(NCT02038920), the Ministry of Health, Labour and Welfare (MHLW) has approved Entyvio for the treatment of adult patients with moderately to severely active Crohn's disease (CD) in Japan.
    • 18 Jul 2018 According to a Takeda media release, based on the data from GEMINI II, GEMINI III [700060538] and CCT001(700240592) company has submitted an Application to the Ministry of Health, Labour and Welfare (MHLW) in Japan for the investigational humanized monoclonal antibody Entyvio for the treatment of adult patients with moderately to severely active Crohns disease (CD) in Japan.
    • 01 Jul 2018 According to a Takeda media release, Takeda received a New Drug Application Approval for Entyvio from the MHLW for the treatment of adults with moderate to severely active ulcerative colitis (UC).

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